Drug Interaction Study With BI 201335 and Methadone or Buprenorphine/Naloxone

Boehringer Ingelheim

Status and phase: Completed; Phase 1

Conditions: Hepatitis C

Treatments: Drug: BI 201335

Study type: Interventional

Funder types: Industry

Identifiers

NCT01637922

1220.57

Details and patient eligibility

About

Otherwise healthy subjects who are currently bein maintained on either methadone or buprenorphine/naloxone for opioid maintenance therapy who have been on a stable dose for at least 30 days will be administered BI 201335 daily to determine if a drug interaction occurs between BI 201335 and either methadone or buprenorphine/naloxone.

Enrollment: 34 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. stable dose of either methadone or buprenorphine/naloxone for 30 days for opioid maintenance therapy.
2. Male and female volunteers with a body mass index (BMI) = 18.5 and < 32 with a minimum weight of 50kg.

Exclusion criteria

1. any other significant medical illness of clinical significance.

2. history of rash or photosensitivity

3. chronic or acute infections including HIV, hepatitis B and hepatitis C.

4. history of allergy considered significant for this study

5. intake of any other medications except for methadone or buprenorphine/naloxone.

6. QTc on electrocardiogram (ECG) > 470.

7. use of any other investigational drug within 30 days of the study.

8. drug or alcohol abuse (other than the defined opioid maintenance therapy with either methadone or buprenorphine/naloxone)

9. blood donation of more than 100mL within four weeks of the trial.

10. excessive physical activities one week prior to and during the trial.

11. any clinically relevant laboratory value.

12. concomitant use of any food product known to alter P450 or P-gp activity such as grapefruit juice, seville oranges and St. John's Wort.

13. inadequate venous access

    For women of childbearing potential:

14. pregnancy or planning to become pregnant within 3 months of the trial

15. positive pregnancy test at screening visit

16. no proof of sterilization or unwilling or unable to use a double barrier method of birth control during the study and up to 3 months after the study.

17. lactation with active breastfeeding from screening up to 30 days after last study visit.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Methadone group

Active Comparator group

Description:

patients on stable methadone therapy (at least 30 days) up to a maximum of 180mg per day

Treatment:

Drug: BI 201335

Drug: BI 201335

Buprenorphine

Active Comparator group

Description:

patients on stable buprenorphine/naloxone therapy (at least 30 days) up to a maximum dose of 24mg/6mg per day.

Treatment:

Drug: BI 201335

Drug: BI 201335